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Senior Development Analyst – R&D 26 views

Job Overview

  • Salary Offer Market Related
  • Experience Level Senior
  • Total Years Experience 5-10

Purpose:

A global pharmaceutical company focused on agile and sustainable growth and complex generics is seeking a Senior Development Analyst who will develop the intellectual property for analytical test methods of all new and existing products, in order to sustain a robust and commercially sound product pipeline, while ensuring that existing products comply with statutory requirements

 

Minimum Requirements:

  • Postgraduate Degree with Honours, Masters or PhD in Science
  • Bachelor’s Degree in Science or National Diploma in Analytical Chemistry
  • 4 to 5 years’ relevant industry experience
  • 7 to 8 years’ relevant experience in in the Analytical Chemistry field
  • Relevant experience in the conduct of analysis in pharmaceutical products, including development, validation and transfer of analytical methods
  • Sound knowledge, understanding and application of international guidelines on the quality of pharmaceutical products, including method development, validation and transfers
  • Sound knowledge and understanding of the quality attributes evaluated for pharmaceutical dosage forms including tablets, capsules, solutions, suspensions, creams and ointments
  • Knowledge scientific principles which underlie the analytical methods and equipment used for such analyses
  • Knowledge, understanding and application of a pharmaceutical quality management system as appropriate for the different stages of the pharmaceutical product life-cycle
  • Sound knowledge and understanding of the quality-by-design concept and its application in analytical method development, as well as formulation development
  • Experience in the review and interpretation of data generated during method development, validation and transfer, as well as formulation development
  • Experience in scientific report writing

 

Key Job Outputs:

  • Plan, organise and execute work as an individual contributor to fulfil the operational requirements of the method development team, which includes
  • Design and present feasible, systematic, science and risk-based approaches to the development of analytical methods, which serve the intended purpose
  • Conduct method development trials/ experiments, following the agreed protocols within the required timelines
  • Assess appropriate pre-validation parameters based on risk to verify a developed-methods
  • Generate scientifically sound analytical development reports which demonstrate robust analytical methods which are fit for the intended purpose
  • Conduct analysis of formulation development lab and pilot trials, including stability
  • Liaise with the formulations team to effectively interpret formulation development data in order to develop suitable finished product specifications which meet regulatory requirements
  • Ensure that method development is effectively used to compile a suitable validation strategy/protocol with the method validation team
  • Critically and effectively conduct analytical method investigations and associated risk assessments as well as the related provision of suitable preventative and corrective actions
  • Design strategies for comparative dissolution studies with the intended purpose in mind
  • Execute agreed protocols and within the required timelines
  • Initiate quality management documentation such as OOS investigations, deviations, change controls, corrective actions and standard operating procedure updates when required with practical, but scientific justifications, risk/impact assessments and root cause analyses
  • Assist the method development manager to effectively and efficiently manage the operations of the method development team
  • Ensure that all results and documents, such as raw data, protocols, reports and certificates of analysis are critically reviewed for accuracy and appropriate scientific rationale, interpretation and conclusion
  • Manage quality management documentation raised in the method development team are critically reviewed
  • Verify that practical, scientific justifications risk/ impact assessments and root cause analyses have been proposed
  • Ensure that the required equipment and consumables are available and are in a suitable state or are of appropriate grade or standard for the execution of work by the method development team
  • Provide formal training as per the training matrix and informal on-the-job training
  • Serve as an alternate responsible person for the key accountabilities of the method development manager in his/ her absence
  • Plan and organise the work allocation of the method development team
  • Provide leadership to the method development team through provision of motivation, conflict management and personal development
  • Monitor the performance of the method development team to ensure that the required standard of work is maintained with a high level of efficiency

Core Competencies:

  • Attention to detail and accuracy
  • Uncompromising on integrity and a commitment to quality of work
  • Organised and professional
  • Ability to think innovatively with sound problem-solving and decision-making skills
  • Team player with sound interpersonal skills and emotional intelligence
  • Sense of urgency and being results-driven with the energy to achieve stretch goals
  • Leadership skills and qualities which includes the ability to lead oneself and a team
  • Strong time management skills which include the ability to work under pressure, prioritising responsibilities and accountabilities while remaining flexible when priorities change
  • Intermediate level computer skills such as MS Office Suite and the Empower System
  • Ability to build inter-team relationships and communicate cordially and professionally within the R&D department
  • Ability to interpret scientific data, draw valid conclusions and present scientific information in written reports and oral presentations which have a logical, organised flow and format

 

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013

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